Kornimate/medical-research-clean huggingface dataset:
desmopressin monotherapy for monosymptomatic nocturnal enuresis

Conditions: Nocturnal Enuresis

Summary: nocturnal enuresis (ne) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years. ne is a common problem that causes distress to both children and their families. it has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. in egypt, the prevalence of ne in primary school children is about 15.4%. the family history was seen to have had a markedly significant impact on the occurrence of ne in the studied children. the mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of mne, disturbed bladder dysfunction in the child with nmne, and instructions about therapeutic strategies. alarm therapy and desmopressin are effective in randomized trials. children with nmne first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis.


Eligibility criteria:
inclusion criteria: * school age group (from 7 to 14 years) * primary monosymptomatic nocturnal enuresis exclusion criteria: patients with one or more of the following will be excluded from the study. * diurnal enuresis * urinary tract infection within the preceding 3 months * diabetes mellitus * history of renal disease, hypertension or genitourinary abnormality, neurological disease, or psychological disease. * post-micturition residual urine \>1/3 expected bladder capacity. * each patient will be subjected to the following.

Keywords: nocturnal enuresis desmopressin monotherapy
effects of mind body exercises in pregnant women

Conditions: Pregnancy Related

Summary: his study is a randomized controlled trial (rct) which will be collected through non probability convenient sampling technique and will be carried out for 10 months duration with a sample size of 34 pregnant women which will be collected through non probability convenient sampling technique. the participants will be divided into two groups. group a will be involved in mind body exercises and group b will be given relaxation exercises

this study is a randomized controlled trial (rct) which will be collected through non probability convenient sampling technique and will be carried out for 10 months duration with a sample size of 34 pregnant women which will be collected through non probability convenient sampling technique. sample will be collected from gosha shifa and ishaq haroon hospital. pregnant women in their second trimester (between 14-28 weeks). age between 20 to 35 years. able to understand and participate in mind-body exercises sessions will be included. high-risk pregnancies (e.g., gestational diabetes, hypertension). pre-existing medical conditions that could interfere with participation (e.g., severe musculoskeletal disorders). will be excluded. tools used in the study are perceived stress scale (pss) , hamilton anxiety rating scale (hars) and fatigue severity scale-(fss).data will be analyzed by busing spss 26.0

Eligibility criteria:
inclusion criteria: * pregnant women in their second trimester (between 14-28 weeks) * primi gravid * able to understand and participate in mind-body exercises sessions exclusion criteria: * high-risk pregnancies (e.g., gestational diabetes, hypertension) * pre-existing medical conditions that could interfere with participation (e.g., severe musculoskeletal disorders) * history of psychiatric disorders requiring ongoing treatment * history of miscarriage

Keywords: pregnant women exercises yoga anxiety fatigue
effect of mulberry fruit powder in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome is a raising concern globally, especially in developing countries such as pakistan. to prevent its risk factors diet and lifestyle modification is major solution. functional foods have additional benefits of treating disease while providing basic nutrients. mulberry is a native fruit with the properties of functional food, it is rich in anthocyanin and different anti-obesity,anti-diabetic, and anti-hyperlipidemic treating potential antioxidants. mulberry will prove its therapeutic potential against the risk factors of metabolic syndrome.

metabolic syndrome, which is characterized by a number of concurrent risk factors. these risk factors include dysglycemia, high blood pressure, high triglyceride levels, low levels of hdl cholesterol, and obesity (particularly central adiposity). it is rapidly increasing the burden of non-communicable diseases (ncds) in pakistan. the prevalence of mets in pakistan is 28.6%, and suburban areas from the province of punjab showed a high prevalence. females are more prone to metabolic syndrome. dietary and lifestyle modification can prevent mets from converting into cvd, t2dm, and stroke. there is limited documented research in pakistan related to the therapeutic roles of mulberry fruit powder. with respect to these limitations, the present study aims to assess the therapeutic roles of mulberry fruit powder consumption on metabolic syndrome. the utilization of dried mulberry fruit powder (mfp) as a component of nutritional supplementation will effectively ameliorate the clinical markers associated with metabolic syndrome.

Eligibility criteria:
inclusion criteria: * subjects having fasting total cholesterol level of ≥ 200 mg/dl or ldl cholesterol ≥ 130 mg/dl. * fasting blood glucose ≥110mg/dl. * sbp ≥ 130/ ≥ 85 mmhg * waist circumference of ≥40 inches in males and ≥35 inches for females exclusion criteria: * participants of age 55 or above * participants who have less than two risk factors

Keywords: hypertension diabetes obesity hyperlipidemia mulberry anthocyanin
validation of safety and efficacy for night shift therapy

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to assess the accuracy of night shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.

the protocol is designed to first evaluate the accuracy of supine vs. non-supine detection in 15 subjects (hereafter referred to as study 1). in study 2, patients who had completed a baseline polysomnography (psg) with a minimum of four hours of sleep time were to wear the night shift for two nights without feedback to confirm their willingness to continue with the study, followed by 28 nights of vibro-tactile position therapy. a follow-up psg was to be conducted as soon as possible to the completion of the 28-nights of treatment. during enrollment subjects were to complete pre-treatment questionnaires designed to measure daytime sleepiness, insomnia severity, depression, anxiety, and quality of life. the same instruments were completed post-treatment on the morning after the 28th night of treatment. subjects completed daily logs to confirm device utilization and identify potential non-device related factors that could influence study completion.

Eligibility criteria:
the inclusion criteria are: * be between the age of 18 and 75 years, * have been diagnosed with obstructive sleep apnea (osa) during polysomnography at a designated sleep center within 4 months of their enrollment, * have not received treatment with any osa therapy for more than 3 days within the past month, * have an overall apnea-hypopnea index (ahi) \> 10 and hypopneas requiring \>3% oxygen desaturation, * having a non-supine apnea-hypopnea index (ahi) \< 15 if continuous positive airway pressure has not been attempted, * have a overall ahi divided by the non-supine ahi \> 1.5, * had an epworth sleepiness score of 5 or more at the time of diagnosis and at the start of therapy, * change in weight of no more than 5 pounds since the diagnostic psg * access to a computer and the internet * sleep is sometime between 8 p.m. to 9 a.m. monday through friday in the same bed exclusion criteria: * neck, back or should pain which would impact ability to sleep laterally each night * body mass index \> 35 * suffering from neurological disorders which result in ticks or tremors * diagnosed with congestive heart failure or chronic obstructive pulmonary disease * suffered from a stroke within the previous 12 months * taking or planning to take narcotic medications * unfamiliar with use of internet browsers * travel (i.e., foreign or cruise ship) which would limit internet or mail access * planned medical procedures (e.g., surgery) which would limit device use during the scheduled 30-day study period or introduce the need for narcotic pain medications

Keywords: obstructive sleep apnea position therapy snoring positional
decrease caregiving fatigue in group leaders of a support group for women after cancer

Conditions: Caregiver Burden

Summary: this exploratory study aims to evaluate the effect of a self-compassion training developed for health professionals on leaders of self-help groups. hypothesis/primary goal: an online group intervention adapted from the "self-compassion for health-care communities program" validated for health professionals leads to an increase in self-compassion among leaders of cancer self-help groups. secondary goals: level of self-compassion at the end of the course as a mediator for therapeutic variables after 6 weeks, decrease in caregiver fatigue, secondary traumatic stress/burnout risk, personal distress and sick leave, decrease in fears of self-compassion/compassion for others; increase in mindfulness, self-efficacy, compassion for others and resilience; direct costs; safety; intervention: online group intervention: led by a certified mindfulness teacher for mindful self-compassion and additional qualification in self-compassion in healthcare communities (duration: 6 weekly appointments of 90 min each); control intervention: waiting group


Eligibility criteria:
inclusion criteria: * group leaders of a self-help group for cancer patients * written informed consent exclusion criteria: * medical or mental condition that, in the opinion of the investigator, does not allow the participant to take part in the study or to provide a legally valid signature of the informed consent (e.g. insufficiently controlled pre-existing mental illness or post-traumatic stress disorder) * lack of willingness to store and share personal health data as part of the protocol * participation in another mindfulness study * lack of knowledge of german

Keywords: self-compassion training cancer care empathy fatigue burnout resilience
a study to evaluate the safety and tolerability of trivalent influenza virus vaccine in children aged 5 years to < 9 years

Conditions: Influenza, Human

Summary: this is a study to assess the safety of a biocsl split virion, inactivated trivalent influenza virus vaccine containing the 2014/2015 northern hemisphere strains of vaccine in children aged 5 years to less than 9 years. comparison will be made to a licensed quadrivalent influenza virus vaccine that complies with the fda recommendations for the 2014/2015 influenza season in the us.


Eligibility criteria:
inclusion criteria: * males or females aged 5 to less than 9 years at the time of first study vaccination. * the subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements. * in good health, as determined by medical history and a targeted physical examination (if warranted). exclusion criteria: * known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs or any components of the study vaccines. * clinical signs of significant active infection or an elevated oral temperature at study entry. * a clinically significant medical or psychiatric condition. * a history of seizures or febrile convulsions or guillain-barré syndrome. * vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry. * vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation. * currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry. * currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine. * currently receiving treatment with warfarin or other anticoagulants.
a clinical trial evaluating the effectiveness and safety of a mmwave radar based sleep respiratory monitoring system

Conditions: Sleep Breathing Disorders

Summary: this study compares the diagnostic capability of a millimeter-wave radar-based sleep respiratory monitoring system to the gold standard polysomnography.

the gold standard for the diagnosis of sleep breathing disorders is polysomnography (psg), which requires contact sensors, in-lab monitoring and manual scoring by experts, limiting the comfortability of patients and accessibility of diagnosis. a novel contactless millimeter-wave radar-based sleep respiratory monitoring system is developed, in order to assist sleep staging and the diagnosis of sleep breathing disorders. the sleep respiratory monitoring system is capable of collecting, recording, storing and analyzing breathing, heartbeat, spatial distribution of full-body movements, etc. via a millimeter-wave radar, and oxygen saturation, pulse, etc. via a pulse oximeter. a dedicated algorithm enables the system to detect respiratory events and estimate sleep stages based on the collected data. the device and algorithms are to be validated in this study by comparison with psg.

Eligibility criteria:
inclusion criteria: * participants is 18 years of age or older. * participants is willing to undergo overnight polysomnography and sleep respiratory monitoring system testing. exclusion criteria: * participants with severe cardiovascular and cerebrovascular diseases, severe liver, kidney, and lung dysfunction. * participants with unstable respiratory diseases, or other diseases in acute phase. * long-term or current use of barbiturates, benzodiazepines, sedatives and other drugs that may affect sleep. * participants that undergo cpap treatment during the night of the trial. * participants with other sleep disorders, e.g. insomnia. * participants with mental disorders. * participants that refuse to sign informed consents. * participants unable to cooperate with medical examination. * participants excluded in the opinion of the investigator.
study to evaluate the safety, efficacy, and pharmacokinetics of recombinant coagulation factor viii fc fusion protein (rfviiifc) in previously treated pediatric subjects with hemophilia a

Conditions: Hemophilia A

Summary: the primary objective of the study is to evaluate the safety of recombinant coagulation factor viii fc fusion protein (rfviiifc) in previously treated pediatric subjects with hemophilia a. secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rfviiifc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (pk) of rfviiifc; and to evaluate rfviiifc consumption for prevention and treatment of bleeding episodes.

previously treated pediatric participants will be treated with a prophylactic regimen of rfviiifc. pk analysis of pre-study factor viii (fviii) and rfviiifc will be performed in a sub-group of the study participants prior to commencement of prophylactic treatment. after these pk results are available, remaining participants have the option of proceeding directly to prophylactic treatment. after completing the end of study assessments, eligible participants would be able to continue treatment in study 8ha01ext.

Eligibility criteria:
key inclusion criteria: * severe hemophilia a defined as \<1 iu/dl (\<1%) endogenous fviii * male \<12 years of age and weight ≥13 kg * history of at least 50 documented prior exposure days to fviii * no current, or history of, inhibitor development to fviii key exclusion criteria: * other coagulation disorders in addition to hemophilia a * history of anaphylaxis associated with any fviii or iv immunoglobulin administration note: other protocol-defined inclusion/exclusion criteria may apply.
hub cleansing to prevent hub infection

Conditions: Bacteremia

Summary: central venous catheter infections are common preventable adverse events among hospital patients. microbes may enter catheter hubs, also known as needleless connectors, and result in downstream contamination. this study aims to compare alcohol disinfection of catheter hubs to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a superior disinfectant at the site of central venous catheter insertion. scrub duration of central venous catheter hubs will also be evaluated.

a prospective randomized blinded crossover clinical trial will be performed in the medical intensive care unit at rush university medical center. the intensive care unit will be divided into two regions (a\&b). hub disinfectants and duration of disinfection will be randomly assigned to these regions. after 1/2 of the study period, the agents will crossover, but the duration of scrubbing will remain the same, analogous to a 2 by 2 factorial design. our primary endpoint will be internal contamination of hubs and catheters. in february 2012 it was determined that the supplier of chlorhexidine and alcohol pads could not completely blind each pad. it was decided that a plain white sticker would be affixed to the front of each pad, but the safety information on the back of each pad would remain visible. 3/27/12-internal hub contamination (yes/no)was clarified as the primary outcome. on 5/10/12 a new sample size calculation adjusted the hub sample size needed to power the main effects based on more accurate information regarding the expected hub contamination rate. the expected hub contamination rate changed because of the more sensitive hub culture method that was adopted before the study began. this more sensitive method also allowed for a new secondary outcome of number of microbial colony forming units per hub. the first crossover time selected was 6/11/12, prior to the midpoint of the study. this was done to try to improve a large imbalance in the group sizes. on 6/11/12 a hold was placed on the catheter tip component of the study, because of an inability to collect tips. on 8/7/12 the catheter tip outcome was dropped because of an inability to collect tips. on 1/11/13 a second crossover was implemented in an effort to balance the sizes of the study groups.

Eligibility criteria:
inclusion criteria: * medical intensive care unit patients with non-tunneled central venous catheters exclusion criteria: * dialysis catheters * antibiotic-impregnated catheters * introducer sheaths * tunneled catheters

Keywords: needleless connectors catheter hubs
long term outcomes of breast intensity-modulated radiation therapy

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast intensity-modulated radiation therapy (imrt) and those that received standard wedge radiotherapy. the cosmetic result, meaning how similar is the treated breast compared to the non-treated breast, will be assessed. also, the occurrence of delayed radiation treatment side effects including tiny red vessels in the skin, breast indurations (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin dryness will be captured.

the canadian breast imrt clinical trial accrued 358 subjects between july 2003 to march 2005. those subjects were randomised between standard radiotherapy using 2d wedge compensation and breast imrt. subjects were treated in toronto, ontario, or in victoria, british columbia. subjects and assessors were carefully blinded to the treatment arm. the clinical trial was funded by the canadian institute for health research (cihr) and one of the four objectives of the application was to "to record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast imrt and conventional irradiation technique". the investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with imrt on the occurrence of late radiation therapy side-effects cosmetic outcome and quality of life.

Eligibility criteria:
inclusion criteria: * subject randomised in the initial breast imrt randomized trial will be eligible for this new study exclusion criteria: * subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.

Keywords: breast irradiation using intensity modulated radiation therapy
bariatric surgery and pharmacokinetics of metoprolol

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on metoprolol are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics metoprolol
advanced perfusion mri of treatment response and progression in glioblastoma

Conditions: Glioblastoma; Glioblastoma Multiforme

Summary: the primary aim of this project is to compare new mscs and standard dsc-pwi methods in gbm patients undergoing post-operative mri for monitoring of tumor progression.

investigators will compare the novel to the standard dsc-pwi methods in twenty five gbm patients to determine whether novel method improves image quality in tumor regions. we will also compare accuracy of pseudoprogression (psp) vs. early progressive disease (epd) determinations by the two techniques. if successful, the project will culminate in a novel imaging method sequence optimized to monitor progression and guide treatment decisions in post-operative gbm patients.

Eligibility criteria:
inclusion criteria: * histology: glioblastoma (grade 4 astrocytoma) * standard-of-care, post-gd t1w image changes suggestive or consistent with of progression. * standard-of-care mri included conventional dsc-pwi without unexpected technical difficulties. * methylation status of tumor available in medical record. * able to provide written informed consent. exclusion criteria: * contraindications either to 3t mri (e.g. certain metallic and electronic implants, claustrophobia) or iv gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency). screening for these contraindications will be based on history only (as it is for all routine outpatient clinical mri at uwhc). * significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, or co-investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest. * special subjects such as minors, mentally disabled persons, or prisoners.